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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000014006
Date of registration: 31/07/2014
Prospective Registration: Yes
Primary sponsor: IBD Center, Sapporo Kosei General Hospital
Public title: Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease
Scientific title:
Date of first enrolment: 2014/08/01
Target sample size: 20
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016314
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Hiroki Tanaka   
Address:  Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan Japan
Telephone: 011-261-5331
Email: hirokit@mtc.biglobe.ne.jp
Affiliation:  Sapporo Kosei General Hospital IBD Center
Name: Satoshi Motoya   
Address:  Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, Japan Japan
Telephone: 011-261-5331
Email: sa-motoya@nifty.com
Affiliation:  Sapporo Kosei General Hospital IBD Center
Key inclusion & exclusion criteria
Inclusion criteria: Patients with active crohn's disease ( CDAI>= 150 and CRP >= 0.3mg/dL ) on 5mg/kg infliximab
Exclusion criteria: 1)Patients whose age below 18 years old
2)Patients with serious infection (sepsis,etc)
3)Patients with active tuberculosis
4)Patients with history of allergy to ingredients of infliximab or to proteins derived from mouse
5)Patients with demyelinating diseases and its past history
6)Patients with congestive heart failure
7)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments


Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
dose escalation of infliximab
Primary Outcome(s)
Relationship between CDAI change and serum infliximab level from week 0 to week 16 and 40 in increased dose period
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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